Clinical trial • Phase IV • Gastroenterology
METFORMIN EMBONATE for Portal hypertension | Cirrhosis
Phase IV trial of METFORMIN EMBONATE for Portal hypertension | Cirrhosis. Randomised, placebo 515 (placebo)-controlled. 76 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Portal hypertension | Cirrhosis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 04-09-2024
Trial design
Randomised, placebo 515 (placebo)-controlled Phase IV trial across 10 sites in France.
- Randomised
- Yes
- Comparator
- Placebo 515 (placebo)
- Target Sample Size
- 76
- Trial Duration For Participant
- 28
Eligibility
Recruits 76 No vulnerable populations selected. Written informed consent to participate is required from participants. Study population restricted to adults (Age ≥ 18 years). No assent or parental consent procedures described..
- Pregnancy Exclusion
- - For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- Vulnerable Population
- No vulnerable populations selected. Written informed consent to participate is required from participants. Study population restricted to adults (Age ≥ 18 years). No assent or parental consent procedures described.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years\n- Absence of hepatocellular carcinoma outside at least one nodule > 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months\n- Written informed consent to participate in the study\n- Medical insurance coverage\n- For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception\n- Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence\n- Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside/nucleotide analog treatment for HBV) for at least 6 months\n- Child-Pugh A or B\n- High likelihood of HVPG ≥ 12 mm Hg based on investigator’s judgement, _confer criteria in the protocole\n- Treatment with carvedilol (≥ 6,25 mg/day) at a stable dose for at least one month"}
Exclusion criteria
- {"criterion_text":"- Serum total bilirubin > 50 µmol/L\n- Prothrombin ratio < 50 %\n- Transaminases > 5 ULN\n- Need for at least one paracentesis for ascites fluid evacuation in the last 6 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- the hepatic venous pressure gradient (HVPG) after 28 days of treatment","definition_or_measurement_approach":"Measurement of hepatic venous pressure gradient (HVPG) after 28 days of treatment"}
- {"endpoint_text":"- Endpoints of the ancillary study: Changes in systemic haemodynamics and HVPG 30 minutes after a meal consisting of two 200 mL bottles of hypercaloric/hyperprotic Fortimel Energy","definition_or_measurement_approach":"Postprandial assessment: changes in systemic haemodynamics and HVPG measured 30 minutes after a standardized meal (two 200 mL bottles of Fortimel Energy)"}
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent is required from participants. Subject information and informed consent form document available (L1_SIS-ICF_2023-504831-42-00_adults). Study restricted to adults (Age ≥ 18 years). No assent or multiple-language consent details provided.
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 76
France
- Earliest CTIS Part Ii Submission Date
- 14-08-2024
- Latest Decision Or Authorization Date
- 02-07-2025
- Processing Time Days
- 322
- Number Of Sites
- 10
- Number Of Participants
- 76
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- BLAISE Lorraine
- Principal Investigator Email
- lorraine.blaise@aphp.fr
- Contact Person Name
- BLAISE Lorraine
- Contact Person Email
- lorraine.blaise@aphp.fr
- Site Name
- Hospital Foch
- Department Name
- service de médecine interne
- Principal Investigator Name
- Sophie HILLAIRE
- Principal Investigator Email
- s.hillaire@hopital-foch.com
- Contact Person Name
- Sophie HILLAIRE
- Contact Person Email
- s.hillaire@hopital-foch.com
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- Anna SESSA
- Principal Investigator Email
- anna.sessa@aphp.fr
- Contact Person Name
- Anna SESSA
- Contact Person Email
- anna.sessa@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- OZENNE Violaine
- Principal Investigator Email
- violaine.ozenne@aphp.fr
- Contact Person Name
- OZENNE Violaine
- Contact Person Email
- violaine.ozenne@aphp.fr
- Site Name
- Centre Hospitalier General De St Denis
- Department Name
- Service d'Hépatogastro-entérologie.
- Principal Investigator Name
- Marion JAGER
- Principal Investigator Email
- marion.jager@ch-stdenis.fr
- Contact Person Name
- Marion JAGER
- Contact Person Email
- marion.jager@ch-stdenis.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- Vincent MALLET
- Principal Investigator Email
- vincent.mallet@aphp.fr
- Contact Person Name
- Vincent MALLET
- Contact Person Email
- vincent.mallet@aphp.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- ROSA Isabelle
- Principal Investigator Email
- isabelle.rosa@chicreteil.fr
- Contact Person Name
- ROSA Isabelle
- Contact Person Email
- isabelle.rosa@chicreteil.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatogastro-entérologie.
- Principal Investigator Name
- Dominique THABUT Dominique
- Principal Investigator Email
- dominique.thabut@aphp.fr
- Contact Person Name
- Dominique THABUT Dominique
- Contact Person Email
- dominique.thabut@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- Ilias KOUNIS
- Principal Investigator Email
- ilias.kounis@aphp.fr
- Contact Person Name
- Ilias KOUNIS
- Contact Person Email
- ilias.kounis@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hépatologie
- Principal Investigator Name
- MOGA Lucile
- Principal Investigator Email
- lucile.moga@aphp.fr
- Contact Person Name
- MOGA Lucile
- Contact Person Email
- lucile.moga@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- METFORMIN
- Active Substance
- METFORMIN EMBONATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (product with EU MP number SCP10310250 listed)
- Maximum Dose
- 1 g/day
- Investigational Product Name
- Placebo 515
- Modality
- Other
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